Abbott FreeStyle Libre ... What is it?
Introduction & Background An evolution of Glucose Monitoring Systems has occurred given that overtime, developers of this system have been able to create a monitoring system that prevent diabetics from pricking their skin. When glucose monitoring systems were first developed for diabetes in 1965, diabetics had to go through the strenuous task of pricking their skin on a daily basis in order to monitor their glucose levels (Hirsch). Today, the new invention: Flash Glucose Monitoring system, developed by Abbott Diabetes Care Inc. (FDA, 2018), allows diabetics to have their glucose levels measured through the use of a sensor that is attached to the glucose machine. The glucose machine is worn around the arm so that the sensor can measure the individual’s glucose reading. After the glucose reading is read by the monitor, the results are given and stored in order to keep a record. The Abbott Freestyle Libre: Flash Glucose Monitoring System, which was approved for public use on July 23rd, 2018, encourages a healthier lifestyle for those who live with type 1 & type 2 diabetes since it helps them monitor and manage their health. For diabetics, being able to monitor and manage their health is especially important since as a result of their failing Pancreas, they are susceptible to other illnesses such as hypertension, atherosclerosis and weight loss (Masharani, 2019). This essay will evaluate the significance of this new development, as well as the legal, social, and ethical implications of using this device. This essay will also evaluate the strength of the Flash Glucose Monitoring System’s security; that is, the extent to which this product is safe for diabetics to use. Abbott Freestyle Libre: Flash Glucose Monitoring System - how it is used Danielle Kirsh, author of the article “The 10 most innovative medical devices of 2018”, states that this updated technology shows real-time glucose readings, as well as trends of the individual’s glucose reading throughout the day. She also states that this new system is able to store all glucose results for up to 90 days. The FDA states that in order to use this newly released device, the sensor that is attached to the monitor must be applied directly onto the back of the upper arm of the skin. The FDA continues to explain that the electrical impulses that are sent from the metal wire of the monitor will generate the result of the individual’s glucose levels. These results are then displayed onto the monitor. It is important to note that the FDA states that the flash glucose monitoring system is designed to replace the fingerstick, which was previously needed for potential insulin treatment. This is''beneficial ''to diabetics since it allows them to better control their glucose through diet and insulin use, without the need of a daily fingerstick, therefore improving their lifestyle. Security health risks According to the article written by “Biomedical Safety and Standards” (2012), there was a recall on February 21st, 2012 stating that the “One Touch Verio IQ Blood Glucose Monitoring Kit” was recalled for “the meter turning itself off when a user attempts to view the results in the “results log” when the log has 256 or a multiple of 256 items to display” (Biomedical Safety and Standards, 2012). As mentioned earlier, Kirsh states that the new Glucose Monitoring System is able to store up to 90 days of glucose results. However, there are no statements released from FDA suggesting the potential risks/problems that can occur in the new Flash glucose monitoring system. In other words, similarly to the recall listed on February 21st, 2012, The Abbott Freestyle Libre glucose monitoring system could have the same failure, causing diabetics to not be able to properly monitor the results of their glucose reading. This could then lead to a security health risk since it would make it more difficult for diabetics to manage their diabetes through diet and exercise. If diabetics do not properly manage their diabetes, Hypoglycemia and Hyperglycemia can occur. Hypoglycemia can lead to seizures or a loss of consciousness (Mayo Clinic, 2019). Hyperglycemia can lead to a coma or shortness of breath (Mayo Clinic,2019). The Abbott Freestyle Libre Glucose Monitoring system may not always be 100% accurate, which may pose health concerns. According to Michael Farkouh, the author of the book “Diabetes and Cardiovascular disease”, “Glucose monitoring systems may not always read the glucose concentrations consistently and accurately” (2019). Being that technology is not always reliable and/or accurate, and as a result of Farkouh’s statement, diabetics should not become too dependent on this type of monitoring system and should always have a back up, which means having machines/meters with test strips and fingersticks. Legal implications As of 2011, according to the CDC, Blood Glucose Monitors that require test strips and fingersticks must be thoroughly cleaned prior to sharing it with another individual in order to prevent the transmission of bloodborne pathogens (CDC, 2011). The CDC further states that if the manufacturer does not provide instructions on how to clean the meter, then the meter should not be shared (CDC, 2011). If the ''health care professional''fails to adhere to protocol as it pertains to the reuse of medical supplies, then he or she may face a lawsuit pertaining to negligence. If an ''individual''fails to adhere to protocol, then he or she is simply at risk of contracting Hepatitis B. Given that the Abbott Freestyle Libre: Flash Glucose Monitoring system does not require the use of a fingerstick in order to monitor glucose levels, an individual is not likely to acquire bloodborne pathogens through transmission as a result of the glucose meter being shared. In other words, Abbott Freestyle Libre is safer to use. However, according to the FDA, this device is not approved for those who are pregnant, or those with complications such as those who are on dialysis, critically ill, those who need an MRI, CT scan, individuals who are dehydrated, and the list goes on. Therefore, in order for health-care institutions to prevent legal consequences, the population in which the health-care professionals can use this product on is limited. Ethical implications The development of this new technology is ethical because developers have developed a safer way for diabetics to collect their glucose reading. Developing a device that significantly reduces the likelihood of transmitting bloodborne pathogens (since a fingerstick is no longer needed) also benefits diabetics since sharing the Abbott Freestyle Libre reduces the likelihood of bloodborne pathogens being transmitted. Also, pricking the skin on a daily basis can cause calluses and scarring (Vann, 2017). Without the need of a fingerstick, calluses and scarring of the finger will not occur. Social Implications Diabetics (with no further complications) may become too comfortable with the updated and advanced glucose monitoring system because they will not have to face the side effects of receiving manual fingersticks as a way to track their glucose reading. As mentioned previously, the negative effects of fingersticks are the transmission of bloodborne pathogens, as well as potential calluses and scarring of the fingers. Understandably, these negative side effects from the old version of glucose monitoring systems could lead to many diabetics not wanting to go back to glucose monitors that require the use of test strips and fingersticks. This is concerning since, as previously mentioned, technology is not always successful. For example, a diabetic will know when to purchase a new Abbott Freestyle Libre when the monitor begins to show inaccurate readings, as Farkouh mentioned. Depending too much on this safer device could also pose a financial burden. Furthermore, the new glucose monitoring system was only developed for a specific group of people, e.g for diabetics who are not blind. The irony is that diabetes can also lead to blindness if the individual does not properly manage it, leaving the individual unable to use this device without assistance. Therefore, the device should be able to speak for better accessibility to those who are impaired. Conclusion & Further required research The Abbott Freestyle Libre- Flash Glucose Monitoring system will most likely become dominant throughout the health-care system, as well as in individual homes. Similar to Blood pressure devices, the new Flash Glucose Monitoring System makes it easier for individuals with illnesses to keep track of and manage their health. As described throughout the essay, this new system is safer to use although diabetics should not become too dependent on it. The fact that developers have invented a way for diabetics to obtain their glucose reading is ethical. However, as discussed, the security risk of using this monitoring system is that shortages and failures may cause the readings to become inaccurate, or for the device to turn off completely, causing this newly developed technology to lose its tenure. Therefore, depending on how long the monitor is expected to last, it may or may not be more reliable. Consequently, further research is required on the life expectancy of this device. Another security health risk is giving special attention to those who are not supposed to use it per FDA warning. The FDA states that the Abbott Freestyle Libre: Flash Glucose Monitoring system is only intended for those who are 18 years of age and older. In other words, those who are born with diabetes or those who develop diabetes at an age prior to 18 years are not expected to use this device. This is concerning given the fact that the daily use of a fingerstick is shown to possibly cause scarring of the fingertips. This is also concerning since the FDA is not giving individuals below the age of 18 the privilege to use a safer device. Therefore, further research should be included with the reasons as to why this device is only intended for those who are at the age of 18 and above.